55484 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section FDA Form 

No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

514.80(b)(4) 2301 190 6.45 1,226 16 19,616 

514.80(b)(5)(i) 2301 190 0.13 25 2 50 

514.80(b)(5)(ii) 2301 190 4.06 772 2 1544 

514.80(b)(5)(iii) 2301 530 0.11 56 2 112 

Total Hours 40,957 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping Total Annual Records Hours per Record Total Hours 

514.80(e)2 530 36.58 19,385 0.5 9,693 

514.80(e)3 530 4.49 2,379 14 33,320 

Total 43,013 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Recordkeeping estimates for § 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932. 3Recordkeeping estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301. 

The reporting and recordkeeping 

burden estimates for this collection of 

information are based on the submission 

of reports to the Division of 

Surveillance, CVM. The total annual 

response numbers are also based on the 

submission of reports to the Division of 

Surveillance, CVM. The annual 

frequency of response was calculated as 

the total annual responses divided by 

the number of respondents. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8023 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0105] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Environmental 

Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 23, 

2006. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: Liz 

Berbakos, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Environmental Impact 

Considerations—(OMB Control Number 

0910–0322)—Extension 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA regulation ‘‘Environmental 

Impact Considerations.’’

The National Environmental Policy 

Act (NEPA) (42 U.S.C. 4321–4347), 

states national environmental objectives 

and imposes upon each Federal agency 

the duty to consider the environmental 

effects of its actions. Section 102(2)(C) 

of NEPA requires the preparation of an 

environmental impact statement (EIS) 

for every major Federal action that will 

significantly affect the quality of the 

human environment. 

The FDA NEPA regulations are in part 

25 (21 CFR part 25). All applications or 

petitions requesting agency action 

require the submission of a claim for a 

categorical exclusion or an 

environmental assessment (EA). A 

categorical exclusion applies to certain 

classes of FDA-regulated actions that 

usually have little or no potential to 

cause significant environmental effects 

and are excluded from the requirements 

to prepare an EA or EIS. Section 

25.15(a) and (d) specifies the procedures 

for submitting to FDA a claim for a 

categorical exclusion. Extraordinary 

circumstances (§ 25.21), which may 

result in significant environmental 

impacts, may exist for some actions that 

are usually categorically excluded. An 

EA provides information that is used to 

determine whether an FDA action could 

result in a significant environmental 

impact. Section 25.40(a) and (c) 

specifies the content requirements for 

EAs for nonexcluded actions. 

This collection of information is used 

by FDA to assess the environmental 

impact of agency actions and to ensure 

that the public is informed of 

environmental analyses. Firms wishing 

to manufacture and market substances 

regulated under statutes for which FDA 

is responsible must, in most instances, 

submit applications requesting 

approval. Environmental information 

must be included in such applications 

for the purpose of determining whether 

the proposed action may have a 

significant impact on the environment. 

Where significant adverse effects cannot 

be avoided, the agency uses the 

submitted information as the basis for 

preparing and circulating to the public 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55485 

an EIS, made available through a 

Federal Register document also filed for 

comment at the Environmental 

Protection Agency (EPA). The final EIS, 

including the comments received, is 

reviewed by the agency to weigh 

environmental costs and benefits in 

determining whether to pursue the 

proposed action or some alternative that 

would reduce expected environmental 

impact. 

Any final EIS would contain 

additional information gathered by the 

agency after the publication of the draft 

EIS, a copy of or a summary of the 

comments received on the draft EIS, and 

the agency’s responses to the comments, 

including any revisions resulting from 

the comments or other information. 

When the agency finds that no 

significant environmental effects are 

expected, the agency prepares a finding 

of no significant impact (FONSI). 

In the Federal Register of March 29, 

2006 (71 FR 15753), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions to which FDA received one 

comment. The comment said it supports 

the current FDA approach to assessing 

potential environmental impact under 

NEPA. However, the comment 

questioned whether one aspect of the 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information has practical utility, and 

contended that eliminating the 

collection of information would 

minimize the burden on respondents. 

Specifically, the comment suggested 

that FDA should ‘‘eliminate 

unnecessary work’’ related to requests 

for categorical exclusions for actions on 

certain investigational new drug 

applications (INDs). Section 25.31 lists 

classes of actions that are categorically 

excluded and, therefore, ordinarily do 

not require the preparation of an EA or 

an EIS. Section 25.31(e) lists an ‘‘action 

on an IND’’ as one of these classes of 

actions. The comment proposed that 

§ 25.31(e) be amended as follows: 

‘‘Action on INDs where the drug or 

biologic product is derived from wild 

plants or animals. Action on other types 

of INDs do not require a claim for a 

categorical exclusion.’’ The comment 

proposed that categorical exclusions 

should be automatically granted for 

actions on INDs where the drug or 

biologic products are not derived from 

wild plants or animals. 

The comment proposed this 

amendment to § 25.31(e) for the 

following reasons, each of which 

suggests that claims for categorical 

exclusion for action on an IND have 

little practical utility and amending 

§ 25.31(e) as proposed represents a way 

to minimize the burden of the collection 

of information: 

1. FDA’s guidance document entitled 

‘‘Environmental Assessment of Human 

Drug and Biologics Applications’’ (July 

1998) states: ‘‘INDs generally involve 

relatively small quantities of a drug or 

biologic product and treatment of a 

limited number of patients. Many INDs 

never result in the filing of an NDA or 

application for marketing approval of a 

biologic product, which would allow for 

the wide-spread commercial sale of the 

product. CDER and CBER will evaluate 

INDs on a case-by-case basis where the 

drug or biologic product is derived from 

wild plants or animals to determine 

whether the extraordinary circumstance 

provision in § 25.21 is invoked.’’ (See 

section III.C.3.b.ii of the guidance 

document). 

2. Pharmaceutical companies have 

been providing claims for categorical 

exclusion for action on an IND since the 

early 1990’s for active pharmaceutical 

ingredients (APIs) in all therapeutic 

classes, and the companies have no 

indication that FDA has used these 

claims as the basis for denials pertinent 

to potential environmental impact as 

described under NEPA. 

3. Usage of an API under an IND is 

‘‘site limited and time bounded,’’

indicating that ‘‘the potential for patient 

excretion of an API to the environment 

is extremely limited.’’

4. The potential risk from 

pharmaceuticals in the environment 

pertains to long-term, chronic exposure, 

and usage of an API under an IND will 

not result in the type of exposure widely 

accepted as being of potential 

environmental concern. The comment 

also stated that prior to marketing 

approval of an API, FDA will have the 

opportunity to review potential 

environmental impact through its EA 

requirements. 

5. The comment concluded that 

amending § 25.31(e) as proposed would 

have ‘‘eliminated work on up to 1933 

categorical exclusions (15,464 hours) for 

INDs in 2005 that ultimately had no 

practical utility.’’

FDA appreciates the comment 

requesting that § 25.31(e) be amended so 

that categorical exclusions could be 

automatically granted for actions on 

INDs where the drug or biologic 

products are not derived from wild 

plants or animals. The purpose of the 

March 29, 2006, Federal Register notice 

and this notice, however, is to afford an 

opportunity for comment on the 

information collection requirements and 

burden estimates for part 25, and to 

request that OMB extend approval for 

that collection. Because the comment 

requests a rulemaking change, we have 

forwarded it to the office in each center 

that is responsible for the information 

collection requirements in part 25 so 

that the comment may be considered for 

any future amendments to the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

Estimated Annual Reporting Burden for 

Human Drugs 

Under 21 CFR 312.23(a)(7)(iv)(e), 

314.50(d)(1)(iii), and 314.94(a)(9)(i), 

each IND, new drug application (NDA), 

and abbreviated new drug application 

(ANDA) must contain a claim for 

categorical exclusion under § 25.30 or 

§ 25.31 or an EA under § 25.40. In 2005, 

FDA received 1,933 INDs from 1,517 

sponsors, 114 NDAs from 94 applicants, 

2,682 supplements to NDAs from 293 

applicants, 777 ANDAs from 161 

applicants, and 4,318 supplements to 

ANDAs from 219 applicants. FDA 

estimates that it receives approximately 

9,813 claims for categorical exclusions 

as required under § 25.15(a) and (d), and 

11 EAs as required under § 25.40(a) and 

(c). Based on information provided by 

the pharmaceutical industry, FDA 

estimates that it takes sponsors or 

applicants approximately 8 hours to 

prepare a claim for a categorical 

exclusion and approximately 3,400 

hours to prepare an EA. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Respondent Total Hours 

25.15(a) and (d) 2,284 4.32 9,813 8 78,504 

25.40(a) and (c) 11 1 11 3,400 37,400 

Total 115,904 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


sroberts on PROD1PC70 with NOTICES
55486 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

Estimated Annual Reporting Burden for 

Human Foods 

Under 21 CFR 71.1, 171.1, 170.39, and 

170.100, food additive petitions, color 

additive petitions, requests for 

exemption from regulation as a food 

additive, and submission of a food 

contact notification (FCN) for a food 

contact substance must contain either a 

claim of categorical exclusion under 

§ 25.30 or § 25.32, or an EA under 

§ 25.40. From 2003 to 2005, FDA 

received an annual average of 88 

industry submissions. FDA estimates 

that it received an annual average of 57 

claims of categorical exclusions as 

required under § 25.15(a) and (d), and 

31 EAs as required under § 25.40(a) and 

(c). 

FDA estimates that, on average, it 

takes petitioners, notifiers, or requestors 

approximately 3 hours to prepare a 

claim of categorical exclusion and 

approximately 210 hours to prepare an 

EA. 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN FOODS1

21 CFR Section No. of Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per Respondent Total Hours 

25.15(a) and (d) 57 1.4 80 3 240 

25.40(a) and (c) 31 1.3 39 210 8,190 

Total 8,430 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Estimated Annual Reporting Burden for 

Medical Devices 

Under 21 CFR 814.20(b)(11), 

premarket approvals (original premarket 

approval applications (PMAs) and 

supplements) must contain a claim for 

categorical exclusion under § 25.30 or 

§ 25.34 or an EA under § 25.40. In 2005, 

FDA received 282 claims (original 

PMAs and supplements) for categorical 

exclusions as required under § 25.15(a) 

and (d), and 0 EAs as required under 

§ 25.40(a) and (c). Based on information 

provided by less than 10 sponsors, FDA 

estimates that it takes approximately 

less than 1 hour to prepare a claim for 

a categorical exclusion and an unknown 

number of hours to prepare an EA. 

TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual Responses Hours per Respondent Total Hours 

25.15(a) and (d) 47 6 282 1 282 

25.40(a) and (c) 0 0 0 0 0 

Total 282 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Estimated Annual Reporting Burden for 

Biological Products 

Under 21 CFR 312.23(a)(7)(iv)(e) and 

601.2(a), IND and biologics license 

applications (BLAs) must contain a 

claim for categorical exclusion under 

§ 25.30 or § 25.31 or an EA under 

§ 25.40. In 2005, FDA received 565 INDs 

from 426 sponsors, 27 BLAs from 12 

applicants, and 737 BLA supplements to 

license applications from 205 

applicants. FDA estimates that 

approximately 10 percent of these 

supplements would be submitted with a 

claim for categorical exclusion or an EA. 

FDA estimates that it received 

approximately 666 claims for categorical 

exclusion as required under § 25.15(a) 

and (d), and 2 EAs as required under 

§ 25.40(a) and (c). Based on information 

provided by industry, FDA estimates 

that it takes sponsors and applicants 

approximately 8 hours to prepare a 

claim for categorical exclusion and 

approximately 3,400 hours to prepare an 

EA for a biological product. 

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS1

21 CFR Section No. of Respondents 

Annual Frequency 

per Response 

Total Annual Responses Hours per Respondent Total Hours 

25.15(a) and (d) 459 1.45 666 8 5,328 

25.40(a) and (c) 2 1 2 3,400 6,800 

Total 12,128 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Estimated Annual Reporting Burden for 

Animal Drugs 

Under 21 CFR 514.1(b)(14), NADAs 

and ANADAs, § 514.8(a)(1) 

supplemental NADAs and ANADAs, 

§ 511.1 (b)(10) investigational new 

animal drug applications (INADs), 

§ 570.35 (c)(1)(viii) generally recognized 

as safe (GRAS) affirmation petitions, 

and § 571.1(c) food additive petitions 

must contain a claim for categorical 

exclusion under § 25.30 or § 25.33 or an 

EA under § 25.40. In 2005, the Center 

for Veterinary Medicine (CVM) has 

received approximately 421 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d), and 14 EAs as 

required under § 25.40(a) and (c). Based 

on information provided by industry, 

FDA estimates that it takes sponsors/ 

applicants approximately 8 hours to 

prepare a claim for a categorical 

exclusion and an average of 2,160 hours 

to prepare an EA. 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55487 

TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Respondent Total Hours 

25.15(a) and (d) 134 3.9 421 8 3,368 

25.40(a) and (c) 12 1.6 14 2,160 30,240 

Total 33,608 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on information provided by 

industry, FDA estimates that the 

combined annual total burden hours for 

all centers is 170,352. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8025 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0380] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Export of Medical 

Devices-Foreign Letters of Approval 

AGENCY: Food and Drug Administration 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing information 

collection, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reporting requirements for firms that 

intend to export certain unapproved 

medical devices. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 21, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857,301–827–1472. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Export of Medical Devices-Foreign 

Letters of Approval (OMB Control 

Number 0910–0264)—Extension 

Section 801(e)(2) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 381(e)(2)) provides for the 

exportation of an unapproved device 

under certain circumstances if the 

exportation is not contrary to the public 

health and safety and it has the approval 

of the foreign country to which it is 

intended for export. 

Requesters communicate (either 

directly or through a business associate 

in the foreign country) with a 

representative of the foreign government 

to which they seek exportation, and 

written authorization must be obtained 

from the appropriate office within the 

foreign government approving the 

importation of the medical device. An 

alternative to obtaining written 

authorization from the foreign 

government is to accept a notarized 

certification from a responsible 

company official in the United States 

that the product is not in conflict with 

the foreign country’s laws. This 

certification must include a statement 

acknowledging that the responsible 

company official making the 

certification is subject to the provisions 

of 18 U.S.C. 1001. This statutory 

provision makes it a criminal offense to 

knowingly and willingly make a false or 

fraudulent statement, or make or use a 

false document, in any manner within 

the jurisdiction of a department or 

agency of the United States. 

FDA uses the written authorization 

from the foreign country or the 

certification from a responsible 

company official in the United States to 

determine whether the foreign country 

has any objection to the importation of 

the device into their country. 

The respondents to this collection of 

information are companies that seek to 

export medical devices. 

FDA estimates the reporting burden of 

this collection of information as follows: 


sroberts on PROD1PC70 with NOTICES